A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 5
- 主要终点
- Incidence rate of dose limiting toxicities (DLT)
研究概览
简要总结
This study was supposed to have assessed the safety and preliminary antitumor activity of CFG920, a new CYP17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant.
The study was terminated after Phase I (dose escalation phase) and Phase II part of the study was not initiated. Novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. As the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of castration resistant prostate cancer
- •Documented metastases
- •ECOG performance status 0 or 1
- •Documented progression following the Prostate Cancer Working Group 2 guidelines
- •Fresh or archived tumor sample
排除标准
- •Impaired cardiac function
- •Uncontrolled hypertension despire appropriate medical therapy
- •History of pituitary or adrendal dysfunction
- •Chronic steriod therapy other than daily use of 10mg prednisone
- •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral CFG920
- •Brain metastases that have not been adequately treated
- •Malignant disease other than that being treated in this study
- •Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
CFG920
干预措施: CFG920 (Drug)
结局指标
主要结局
Incidence rate of dose limiting toxicities (DLT)
时间窗: 28 days (from the time of first dose)
Phase l; cycle = 28 days
Incidence rate of patients with Prostate Specific Antigen (PSA) response
时间窗: >= 12 weeks
Phase ll only
次要结局
- PK parameters(18 months)
- Number of adverse events (AEs)(18 months)
- Progression free survival (PFS)(baseline, until disease progression up to 6 months (6 cycle))
- Number of serious adverse events (SAEs)(18 months)
- Radiological Time to Progression (rTTP)(baseline, until date of documented disease progression)
- Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)(18 months)
- Best PSA response at any time during the study(18 months)
- Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)(18 months)
- Time to PSA progression(up to 2 months (cycle 2))
- Overall Response rate (ORR)(up to 2 months (cycle 2))